The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy

NCT04116021 | Unknown Phase 4

• 1 other identifier: PECS 2019
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. The other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. Investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.

Conditions

Breast Cancer

Keywords

mastectomy

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Cumulative intravenous morphine consumption (mg)

  first 24 postoperative hours

Secondary Outcomes (7)

• Pain score at rest at 2 hours postoperatively

  2 hours postoperatively

• Pain score at rest at 12 hours postoperatively

  12 hours postoperatively

• Pain score at rest at 24 hours postoperatively

  24 hours postoperatively

• Pain score on movement at 2 hours postoperatively

  2 hours postoperatively

• Pain score on movement at 12 hours postoperatively

  12 hours postoperatively

Study Arms (2)

PECS block

ACTIVE COMPARATOR

Ultrasound-guided pectoral nerve block with bupivacaine 0.5 % 30 mL before surgical incision

Other: PECS block

Wound infiltration

ACTIVE COMPARATOR

Wound infiltration with bupivacaine 0.5 % 30 mL at the end of surgery

Other: Local infiltration

Interventions

PECS block OTHER

Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %

PECS block

Local infiltration OTHER

Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %

Wound infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral mastectomy
• American Society of Anesthesiology Physical Status I-III
• Age ≥ 18

You may not qualify if:

• Contraindications to regional anesthesia, such as infection at the surgical site
• Pregnancy
• History of alcohol or drug dependence/abuse
• History of long term opioid intake
• Chronic pain disorder

Sponsors & Collaborators

• Hôpital du Valais: lead
• University of Lausanne Hospitals: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sina Grape

  Hopital du Valais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sina Grape, MD

CONTACT

0041276038759; sina.grape@hopitalvs.ch

Eric Albrecht, MD

CONTACT

0041763281145; eric.albrecht@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers and outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share